Sira Pharma Consultancy

Welcome

Get Know About Us!

We are a pharmaceutical regulatory service provider, founded by industry veterans with a wealth of experience in the field. Our mission is to provide top-notch regulatory services to pharmaceutical companies, helping them navigate the complex landscape of pharmaceutical regulations.

Our founders, with their extensive experience and deep understanding of the pharmaceutical industry, have instilled a culture of excellence and a commitment to quality in our organization. We understand the challenges faced by pharmaceutical companies in complying with regulatory requirements and are here to offer our expertise and support.

Our services include regulatory consulting, submission of regulatory documents, liaison with regulatory authorities, and much more. We are committed to providing our clients with reliable, efficient, and cost-effective solutions to meet their regulatory needs.

We believe in building strong relationships with our clients, based on trust, transparency, and mutual respect. We work closely with our clients to understand their specific needs and provide customized solutions that align with their business objectives.

Thank you for visiting our website. We look forward to the opportunity to serve you.

Mission

Our mission is to provide comprehensive regulatory affairs consulting services to pharmaceutical companies worldwide. We aim to navigate the complexities of global pharmaceutical regulations, ensuring our clients’ products meet the highest standards of safety, efficacy, and quality. We strive to expedite the regulatory approval process, enabling our clients to bring their innovative and products to market as quickly as possible.

- Sira Pharma consultancy

Core Values

Integrity

We uphold the highest ethical standards in all our work & maintaining transparency in our dealings with clients and regulatory authorities.

Excellence

We strive for excellence in all we do, continually improving our skills and knowledge to provide our clients with the best possible service.

Customer Focus

We put our clients at the center of everything we do, striving to exceed their expectations and help them achieve their business objectives.

Professionalism

We conduct ourselves with professionalism at all times, demonstrating competence, reliability, and respect for our clients and colleagues.

Quality

We are committed to providing services of the highest quality, ensuring that all regulatory submissions are accurate, complete, and compliant with all relevant regulations and guidelines.

Confidentiality

We understand the sensitive nature of the information we handle and are committed to maintaining strict confidentiality and data security protocols.

We look forward to partnering with you on your journey to regulatory approval and market success.

Our Advantage

Expert Guidance: We provide strategic advice on regulatory submission and compliances.

Streamlined Processes: We handle every step from pre-approval to post-approval.

Risk Mitigation: Our in-depth knowledge helps you avoid potential fines and noncompliance.

Cost Savings: We devise strategies that expedite the registration, saving you time and money.

Customized Solutions: We tailor our services to meet your specific needs.

Faster Time to Market: Our efficient processes can help you bring your product to market quicker.

Our Industries

We assist clients with quality and regulatory needs in multiple life science industries.

Our Services

We provide unique and professional services in Regulatory Affairs, Quality assurance, and clinical matters. Our technical proficiency, accessibility, and cost-effective rates are aspects you can rely on.

We assist our client in many areas, Including.

Regulatory Affairs

Strategy

Domestic & Foreign Submissions

Tech Filess

Registration & Licensing

Compliance

Auditing – Internal & Supplier Audits

Query & Warning Letter Response

Mock Inspections

Audit Readiness

Quality Assurance

Development of QMS

Gap Analysis

CAPA | Complaint handling

Validation

Qualifications of equipments

Reach out to us today to explore your requirements and see how our top-tier expertise can transform your business.

Regulatory Affairs

The regulatory environment is constantly evolving.
Our team of seasoned professionals guarantees adherence to these changes.

Regulatory Strategy
We help clients develop a comprehensive regulatory strategy that aligns with their business objectives and ensures compliance with all relevant regulations.

Regulatory Submission

We assist clients in preparing and submitting regulatory documents to the appropriate regulatory authorities. This includes MAA, ANDA, DMF and renewals, etc

Regulatory Compliance

We help clients ensure their operations, processes, and products are compliant with all relevant regulations includes ICH, US CFR and etc.

Post-Marketing Surveillance:

We assist clients in monitoring the safety and effectiveness of their products after they have been launched on the market.

Liaison with Authorities

We act as a liaison between clients & regulatory authorities, facilitating communication and ensuring a smooth regulatory process.

Labeling and Promotional Material:

We prepare and review product labeling and promotional materials to ensure they are compliant with regulatory requirements

Quality Assurance

Our team is skilled in the development and enhancement of quality systems that adhere to ICH, 21 CFR, and other standards.

Quality System management

We assist clients in the preparation of Policies Process and Procedures that comply with all current regulations.

Audit Service

“We perform a variety of audits, both onsite and remotely, which include supplier audits, internal audits, simulated FDA inspections, and process audits.

Gap Analysis

Our thorough Gap Assessments scrutinize processes and pinpoint areas that need enhancement.